1. Field of the Invention
The present invention relates generally to the field of surgery generally and to dental surgery specifically.
2. Description of the Background
Oral surgeries are performed routinely in the dental field to correct a variety of problems including impacted teeth, infections, periodontally involved teeth, removal of broken or fractured teeth, bone grafts, and/or dental implants. The recovery following dental surgery is often protracted and painful, leading to a great deal of suffering among patients. Following the removal of a tooth, bone formation may take as long as 16 to 24 weeks. Similarly, patients who have suffered a broken bone are commonly confronted with a slow and painful recovery. Accordingly, the medical profession is constantly in search of tools and formulations for the reduction of pain and the improvement of patient recovery time following bone-impacting surgeries or injuries.
Dexamethasone sodium phosphate solution is an FDA-approved, synthetic glucocorticoid steroid hormone. It is commonly employed as an anti-inflammatory agent after surgery. In the laboratory, dexamethasone sodium phosphate solution also been shown to induce osteoblast differentiation in cell culture. Hayami et al. demonstrated that media supplemented with dexamethasone sodium phosphate solution increased osteoblast-specific cell markers in culture. Hayami T, Zhang Q, Kapila Y, Kapila S. “Dexamethsone's enhancement of osteoblast markers in human periodontal ligament cells is associated with inhibition of collagenase expression.” Bone. (2007) 40(1):93-104. Another commonly employed glucocorticoid is triamcinolone hexacetonide, which is sold under the trade names ARISTOSPAN and KENALOG-10.
Platelet-rich-plasma (PRP) is a highly concentrated suspension of platelets with minimal plasma that has been used as a healing aid. To obtain PRP, blood is withdrawn from a patient and centrifuged, resulting in distinct layers in the blood. Through the isolation of one of the layers (buffy coat), a volume of PRP may be obtained. That PRP suspension may be applied to a site of a wound to promote healing. PRP's use has been clinically shown to decrease healing time for patients undergoing surgical procedures (e.g., extractions, bone grafts, implant placement) as well as decrease the incidence of complications resulting from the surgery. While generation of PRP involves additional steps for its production, whole blood may be more easily obtained from patients—either from direct extraction at the surgical site or by employing standard phlebotomy techniques.
There has been a long-standing need in the oral surgery field for methods and formulations that improve the recovery of patients following bone-impacting injury or surgery. Preferably, such formulations and methods would be able to be implemented routinely and efficiently and would be within the scope of the typical procedures employed by the dental practitioner. The present inventor surprisingly identified formulations in which the beneficial effects of a blood component, such as PRP or whole blood, are synergistically improved by the additional of pharmaceutical agents, particularly dexamethasone, triamcinolone hexacetonide, vitamin K2, purmorphamine, melatonin, 17β-estradiol, and bisphosphonates such as alendronate.